Method and apparatus for hemostasis

ABSTRACT

Devices and methods are disclosed for achieving hemostasis in traumatized patients. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery or military setting. In such cases, the patient may have received trauma to abdominal viscera, the thoracic cavity or the periphery. The devices utilize fluid impermeable outer surfaces and distributed pressure to achieve tamponade and hemostasis, primarily by exertion of pressure. The devices are flexible, bendable, and conformable in their wet or dry state so that they exert distributed pressure on the wound. Peripheral haemostatic packing devices include optional adhesive structures to attach one packing device to another. The hemostatic packing devices may be placed and removed by open surgery or laparoscopic access without generating excessive re-bleeding. The devices can be inserted into a wound and filled with fluid, gel, or particulates through an axially elongate tube to generate pressure to tamponade the wound.

RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 12/012,084, filed Jan. 31, 2008, now U.S. Pat. No. 7,943,810,which is a Continuation-in-Part of U.S. patent application Ser. No.11/087,224, filed Mar. 23, 2005 now U.S. Pat. No. 7,329,792 which is aContinuation-in-Part of U.S. patent application Ser. No. 10/358,881filed Feb. 4, 2003, now U.S. Pat. No. 6,998,510 the entirety of all ofwhich are hereby incorporated herein by reference, and claims prioritybenefit under 35 USC §119(e) from U.S. Provisional Application No.60/555,537 filed Mar. 23, 2004, entitled “METHOD AND APPARATUS FORPERIPHERAL HEMOSTASIS”, the entirety of which is hereby incorporatedherein by reference.

FIELD OF THE INVENTION

The field of this invention is wound care during trauma surgery, generalsurgery, combat medicine, and emergency medical services. The inventionis applicable to animals, especially including mammals, and is directedprimarily at use on humans.

BACKGROUND OF THE INVENTION

As recently as the early 1990s, surgical operations for trauma weredirected at the anatomic repair of all injuries at time of the initialoperation. It was observed during these exercises that many patientsbecame hypothermic, acidotic, and coagulopathic. Patients showing thesethree signs often died. Death often occurred in the operating room dueto exsanguinations, or postoperatively, due to the complications ofprolonged shock and massive transfusion to replace blood lost as aresult of the trauma.

One of the most notable developments in the recent evolution of surgeryhas been the introduction of the concept of staged laparotomy toovercome the deficiencies of the repair all-at-once approach. This newstrategy of staged laparotomy, employing new tactics that have beentermed damage control, is now used in 10% to 20% of all traumalaparotomies.

This damage control strategy opens the way for a variety of new devicesand methods for a) control of hemorrhage from solid organs or viscera,b) control of hemorrhage from peripheral wounds and peripheral vascularlacerations, and c) control of contents spillage from hollow viscera.Although there are procedures for controlling these injuries, none ofthese procedures utilize optimal devices or tactics in their execution.Each area offers technological opportunities to improve the devices andprocedures for applying those devices.

Ever since the advent of abdominal surgery, surgeons have relied on thesame thinly woven cotton gauze packing pads that are currently in favor.These gauze pads are called laparotomy pads or Mickulitz pads. Thesepads were designed for use as sponges but not for use as hemostatictampons. Nonetheless, since World War I, surgeons faced with severebleeding have relied on packing patients with these sterilizable gauzesponges in an effort to control bleeding. Since World War II, it hasbeen known that abdominal packing using these pads has been associatedwith abdominal sepsis and re-bleeding after pad removal. Despite theselimitations, even today, they are the mainstay of damage controlhemostasis.

The specific issues with the gauze pads are that they are porous andallow the free passage of blood through the mesh. Other unfavorablecharacteristics include the lack of intrinsic coagulation inducingproperties. The pads are easily saturated and they do not stick to oneanother. The pads are capable of promoting infection because they serveas a nidus for bacteria in a contaminated field. They have no intrinsicantiseptic or antimicrobial action. These pads are unsuitable forpacking solid viscera because they stick to the visceral wound tissueand cause re-bleeding upon removal. Although generally recognized assub-optimal, the gauze pads have the advantages of being cheap, familiarand ubiquitous. For these later reasons, they continue to remain themainstay of damage control hemostasis. Among the opportunities for newtechnologies and instruments to support the process of damage control,the first requirement is an improvement in the surgical pack and forcontrol of peripheral hemorrhage through an open wound through the skin.

Other current pads for hemostasis include gel-foam, Surgical, and fibrinsponges. These devices are all liquid permeable and require bloodcoagulation to occur before impermeability and hemostasis are achieved.In addition, the fibrin sponges are very rigid and will not conform to awound while in the dry state. Typical examples of the prior art inhemostatic packing systems include U.S. Pat. No. 5,643,596 to Pruss etal., U.S. Pat. No. 5,763,411 to Edwardson et al., U.S. Pat. No.5,800,372 to Bell et al., U.S. Pat. No. 6,054,122 to MacPhee et al., andU.S. Pat. No. 6,056,970 to Greenawalt et al. These patents, all of whichare included herein by reference, disclose permeable hemostatic packingand dressings with topical hemostatic coatings. These devices all servethe purpose of stopping bleeding in underlying vessels with an occlusivebacking but the backing is still permeable to blood leakage. The lack ofimpermeability in these prior art patents is not recognized as an issue.

While hemostatic packing devices are well known in the art, the utilityof said packing devices is limited by their propensity to harborpathogens and their propensity to create re-bleeding by adherence tohealing surfaces. One device uses a powdered hemostatic agent that ispoured into a wound. The hemostatic agent reacts with the blood,withdrawing water from the blood and causing rapid thrombosis to occur.This agent, however, aggravates the spread of infection and is difficultto remove when definitive repair takes place. The reaction with theblood is exothermic and causes undesirable, localized tissue heating.Further, there is no inherent mechanism to hold the hemostatic agent inplace in the wound other than application of a separate coveringbandage. In addition, current devices adhere to a wound or surroundingtissue by adhesive methodologies. In an acute or emergency setting theremay be profuse bleeding, water, oil, mud, or other contaminants thatdefeat an adhesive and prevent sticking. Current bandages can controlbleeding that weeps from a wound because of pressure restrictions but donot control major vessel hemorrhage because they cannot stop the flow ofblood at unrestricted systemic arterial pressure.

New devices, procedures and methods are needed to support the strategyof damage control in patients who have experienced massive bodilyinjury. Such devices and procedures are particularly important in theemergency, military, and trauma care setting. These new devices rely onthe principles of impermeability to blood passage, limited nidusformation for bacteria, the ability to carry prothrombogenic material,and the lack of intrinsic thrombogenicity except by providing a physicalbarrier or pressure source.

SUMMARY OF THE INVENTION

This invention relates to an improved hemostatic packing device for usein trauma care. The present invention is an impermeable barrier pack orwrap for a body appendage. Other features of the pack includefoldability and moldability to the anatomical surface. The exteriorsurface of the pack is not intrinsically thrombogenic but is capable ofserving as a carrier for thrombogenic substances. Said thrombogenicsubstances can be liquids or solids but are, preferably gels withinternal cohesion and spreadability. Certain regions of the exteriorsurface of the pack may optionally comprise thrombogenic properties. Thepack may be made with a plurality of surfaces, each with distinctcharacteristics. An exemplary version of the pack has a thin layer ofpolyethylene or polypropylene, which is impermeable to liquids, coveringits entire outer surface. A key advantage of the present invention, inits wet or dry state, is moldability, flexibility and shapeability tothe anatomical contacting surface, including the ability to pack woundsin solid viscera. The pack is able to distribute pressure within thewound to generate pressure tamponade. The pack is capable of generatingpressure tamponade without regions of sharp or high stress such as wouldbe generated by a rigid packing system. This improvement over certainvery hard packing devices allows for better fit to the anatomy and theimmediate formation of an impermeable barrier without the need to waitfor blood coagulation to occur to form the hemostatic barrier. Thehemostatic pack of the present invention is placed via open surgery orthrough laparoscopic instrumentation. The laparoscopic embodimentincludes the capability of reversibly or irreversibly achieving a sizeand mass change in the device once it is placed within the patient.

The present invention distinguishes over the cited prior art because itrequires no thrombogenic coatings, although it is capable of trappingand carrying such pro-thrombogenic coatings on its surface. The outersurface of the haemostatic packing sponge serves as a carrier byincorporating indents or villi to physically hold the pharmacological,thrombogenic or antibacterial coatings. Since the surface is impermeableto liquids, the arrest of hemorrhage is immediate and does not requirethrombosis to occur. When the packing device of the present invention isremoved from the patient, re-bleeding does not occur because there isnot penetration of the wound tissues or clot into the interstices of thepack. An additional advantage of the impermeable pack is a resistance tobacteria and other pathogenic penetration. In another embodiment, thehemostatic pack comprises two or more layers of material havingdifferent compressibility and resilience. The different materialproperties can be achieved by different manufacturing processes toachieve, for example, different pore sizes and wall thicknesses in afoam structure, or by pre-compressing the foam to different degrees, orboth.

In another embodiment of the invention, the pack, or wrap, comprisesraised ridges or dams on its surface. These ridges or dams are comprisedof soft, conformable, or elastomeric, materials that form an edge sealto prevent the escape of blood from a wound. The pack, or wrap,optionally comprises additional regions or borders of enhanced bloodclotting or thrombogenesis to assist with the hemostatic properties ofthe device.

In yet another embodiment of the present invention, the hemostatic packcomprises adhesives, fasteners, or the like to allow the packs to adhereto each other, thus forming a syncytium, or contiguous barrier comprisedof more than one component, to prevent blood from escaping from a wound.

In another embodiment of the invention, the hemostatic pack is a bandageor peripheral hemostasis system (PHS) that is worn over a vascular woundthat communicates with the exterior environment of the patient through abreak in the skin. Such wounds, particularly in the extremities of thepatient such as the head, neck, arms, legs, hands, and feet, may includesevere vascular damage that could result in bleeding to death, ornear-exsanguination with its concomitant complications. In anembodiment, a bandage or PHS is described that comprises one or moreexternal dams that are held against the skin surrounding the wound byforce sufficiently capable of sealing the wound from blood leakage. Theregion inside the dams is bounded by the dams at the perimeter, a liquidimpermeable barrier on the exterior, and the skin and wound on theinside. Blood cannot escape from this region as long as the seal betweenthe dam and the skin is intact. This device is most efficacious onpatient extremities since the vasculature is typically surrounded byintramuscularly tissue, which cannot be tunneled by blood hemorrhageunder systemic arterial pressure to cause blood pooling. In the thorax,abdomen, or pelvic region, internal body cavities can fill withpressurized blood so the hemostatic pack or wrap is less efficacious inthese regions.

In yet another embodiment of the invention, the bandage or PHS comprisesa strap to hold the dam and fluid or liquid impermeable region over thewound. The strap, in a preferred embodiment comprises some elasticityand further comprises a fastener that is adjustable. The strap, inanother embodiment, further comprises a standoff, which is a rigid orsemi-rigid member that prevents the strap from circumferentiallyconstricting the appendage around which the strap is wrapped, yet whichallows the strap to pull the dam and fluid impermeable region againstthe tissue surrounding the wound. The dams and liquid impermeable regiontherebetween are held against the skin by force in substantially onedirection only, not a circumferential or radial force. In yet anotherembodiment, the bandage comprises a central packing device to exertpressure on the wound to facilitate tamponade. This central packingdevice may be a folded fabric pad, a sac or a bladder filled withliquid, gas, gel, foam, powder, or the like. The central packing devicemay also simply comprise an externally communicating port that allowsgas or liquid to be infused into the region between the dams, the liquidimpermeable layer and the skin. The gas or liquid may be pressurized toexceed systemic arterial pressure and thus tamponade the wound. In yetanother embodiment of the invention, the bandage comprises an inner damand an outer dam. A vacuum drawn on the region between the inner dam andthe outer dam, through a port that communicates through the fluidimpermeable layer between the two dam regions, holds the bandage againstthe skin and prevents blood escape under systemic arterial pressure. Inanother embodiment, the region between the dams comprises hemostatic,bioadhesive, or thrombogenic agents to assist with sealing the bandageto the skin surrounding the wound and preventing blood loss past thedams. In an embodiment, the hemostatic or bioadhesive agents arepre-applied to the bandage in a dry state or are dried afterapplication, wherein the hemostatic or bioadhesive agents are inactiveuntil wetted by the presence of blood or other liquids containing water.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention are described herein. It is to beunderstood that not necessarily all such advantages may be achieved inaccordance with any particular embodiment of the invention. Thus, forexample, those skilled in the art will recognize that the invention maybe embodied or carried out in a manner that achieves one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

A general architecture that implements the various features of theinvention will now be described with reference to the drawings. Thedrawings and the associated descriptions are provided to illustrateembodiments of the invention and not to limit the scope of theinvention. Throughout the drawings, reference numbers are re-used toindicate correspondence between referenced elements.

FIG. 1A illustrates a two-sided hemostatic pack comprising a sheet ofmaterial that is impermeable to liquid on one side and the other side isa permeable fabric affixed to the impermeable barrier, according toaspects of the invention;

FIG. 1B illustrates a cross-sectional view of the two-sided haemostaticpack, according to aspects of the invention;

FIG. 1C illustrates the two-sided hemostatic packing device folded withthe impermeable surface facing outward toward the wound surface,according to aspects of the invention. In this embodiment theimpermeable surface is on both sides of the device;

FIG. 1D illustrates the two-sided hemostatic pack rolled with theimpermeable side out, according to aspects of the invention;

FIG. 2 illustrates a hemostatic packing device comprising a closed-cellfoam that is impermeable on both sides, according to aspects of theinvention;

FIG. 3 illustrates a hemostatic packing device comprising an outersurface that is impermeable on both sides where the upper surfacefurther comprises indentations capable of carrying exogenousthrombogenic substances, according to aspects of the invention;

FIG. 4 illustrates a hemostatic packing device comprising a polygonaldeformable solid with an impermeable outer surface, according to aspectsof the invention;

FIG. 5A illustrates an inflatable hemostatic packing device thatcomprises an impermeable outer surface, and an internal bladder that iscapable of containing material, where said material when reversiblyintroduced into the bladder through a sealing port, is in the form ofsolid particles, a fluid, or a combination thereof, according to aspectsof the invention;

FIG. 5B illustrates one embodiment of the inflatable hemostatic packingdevice in its deflated or partially deflated state, according to aspectsof the invention;

FIG. 6 illustrates a hemostatic packing device being introduced into apatient through a laparoscopic instrument, according to aspects of theinvention;

FIG. 7 illustrates a hemostatic packing device comprising an adhesive onat least a portion of the outer impermeable surface of said hemostaticpacking device, according to aspects of the invention;

FIG. 8 illustrates a hemostatic packing device comprising a packingmaterial with an impermeable outer surface affixed to an adhesiveimpermeable drape, according to aspects of the invention;

FIG. 9A illustrates a wound of the liver, according to aspects of theinvention;

FIG. 9B illustrates the wound of the liver being treated by applicationof internal tamponade of hemorrhage with the impermeable hemostaticpacking device used in a peri-hepatic location, according to aspects ofthe invention;

FIG. 10A illustrates a wound of an exemplary extremity, the thigh, withfemoral artery transection, according to aspects of the invention;

FIG. 10B illustrates the wound to the thigh being treated by applicationof an impermeable hemostatic packing device with the adhesiveimpermeable drape, according to aspects of the invention;

FIG. 11 illustrates a wound dressing, PHS, or bandage for treating awound to the arm or the leg comprising a blood dam, according to aspectsof the invention;

FIG. 12 illustrates a wound dressing, PHS, or bandage for treating awound to the arm or the leg comprising a series of blood dams, accordingto aspects of the invention;

FIG. 13 illustrates a wound dressing, PHS, or bandage for treating awound to the arm or the leg comprising a blood dam with a communicatingvalve, according to aspects of the invention;

FIG. 14A illustrates a lateral sectional view of two internal hemostaticpacks for solid organs, viscera, and the like, comprising an adherentregion for joining the two packs, wherein the adherent region comprisesa porous adhesive element but further comprises a plurality ofnon-porous barrier regions or dams, according to aspects of theinvention;

FIG. 14B illustrates a lateral sectional view of two internal hemostaticpacks that have been joined together to form a syncytium wherein thebarrier regions or dams render the adherent region impermeable to fluidssuch as blood, according to aspects of the invention;

FIG. 15 illustrates an oblique view of a preferred wound dressing, PHS,or bandage for treating a wound to a body part comprising a strap, ablood dam, and a pillow pack, according to aspects of the invention;

FIG. 16 illustrates an oblique view of a wound dressing, PHS, or bandagefor treating a wound to a body part comprising a strap, a plurality ofconcentric blood dams, lateral stiffeners and a liquid impermeablecentral region, according to aspects of the invention;

FIG. 17A illustrates a side cross-sectional view of a wound with abandage or PHS comprising a liquid impermeable region surrounded by adam or gasket wherein the dam or gasket edge is rounded and is pressedinto the skin surrounding the wound, according to aspects of theinvention;

FIG. 17B illustrates a side cross-sectional view of a wound with abandage or PHS comprising a fluid access port and valve and a liquidimpermeable region surrounded by a dam or gasket wherein the gasket hasa rounded triangular cross-section, according to aspects of theinvention;

FIG. 18 illustrates an oblique view of a wound dressing, PHS, or bandagefor treating a wound to a body part comprising an optional strap, aplurality of nested blood dams, a stiffening scrim, a central liquidimpermeable region, a vacuum port, and vacuum manifold, according toaspects of the invention;

FIG. 19 illustrates a cross-sectional view of an appendage with a woundand a bandage, or PHW, attached thereto. The bandage includes a standoffto prevent a tourniquet effect to the limb, according to aspects of theinvention;

FIG. 20 illustrates a cross-sectional view of an appendage with a woundand a peripheral hemostasis system attached thereto. The peripheralhemostasis system includes a rigid or semi-rigid cuirass to apply afluid-tight barrier over the wound without creating a tourniquet effect,according to aspects of the invention;

FIG. 21A illustrates a side breakaway view of a hemostatic packcomprising an inner, high spring-force layer surrounded by a softerconformable layer, the entire pack surrounded by an outer, fluidimpermeable layer, according to aspects of the invention; and

FIG. 21B illustrates a lateral view along cross-section A-A of thehemostatic pack of FIG. 21A, according to aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is therefore indicatedby the appended claims rather than the foregoing description. Allchanges that come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

FIG. 1A illustrates a diagram of a two-sided hemostatic packing device10 of the present invention. The two-sided packing device 10 comprises asubstrate 12 and a fluid impermeable surface 14. The fluid impermeablesurface 14 further comprises an optional adhesive layer 16, and aplurality of optional indentations 18. The fluid impermeable surface 14or the substrate 12 may optionally comprise a plurality of radiopaquemarkers 20.

Referring to FIG. 1A, the hemostatic packing device 10 is a flat sheetconfiguration that is flexible and deformable. The substrate 12 is aflat sheet configuration and is integral to or affixed to the fluidimpermeable surface 14. The adhesive 16 is used to affix the substrateto the fluid impermeable surface. The fluid impermeable surface 14optionally comprises a plurality of indentations 18. The radiopaquemarkers 20 may be wire form, dots or patches of barium-impregnatedfabrics.

Referring to FIG. 1A, the substrate 12 is fabricated from cotton gauze,open or closed cell foam, sponge, fluids, particulates and the like. Thesubstrate 12 is soft in its wet or dry state and may be bent, molded ordeformed to maximize surface contact and force distribution on theinjured tissue. The foam configuration of the substrate 12 is fabricatedfrom materials such as polypropylene, polyvinyl chloride, polyurethane,polyethylene, silicone rubber, poly methyl methacrylate, polyvinylalcohol and the like. The foam configuration of the substrate 12 may bepre-compressed, or partially pre-compressed, to achieve the correctamount of hardness, or it can be fabricated in a plurality of layers.For example, the foam substrate 12 can have an inner layer of hard foamand an outer layer of softer foam. The outer layer of softer foam helpsto fill space and conform to irregular geometries while the inner layerof harder foam helps to provide the packing force necessary to overcomesystemic arterial pressure. The particulates of the inflatableembodiment of substrate 12 may be beads of collagen, PTFE, silica andthe like. The fluid impermeable surface 14 is fabricated from materialssuch as polypropylene, polyvinyl chloride, polyurethane, polyethylene,silicone rubber, poly methyl methacrylate, polyvinyl alcohol, Tyvek andthe like. The fluid impermeable surface 14, in another embodiment, isfabricated from materials such as paper or cloth that is then coated orsprayed with impermeable materials such as polyethylene, polypropyleneand the like. The use of rip-stop fabrics will help prevent tearing ofthe fluid impermeable surface 14.

The hemostatic packing device 10 is fabricated in a variety of sizes andthicknesses. The thickness varies from 0.1 mm to 50 mm. The length andwidth each may vary from 5 mm to 500 mm. The geometry is generallyrectangular but may have triangular, circular, or polygonalconfigurations. The corners may be square or rounded.

The radiopaque markers 20 are fabricated from a group of materialsincluding but not limited to barium impregnated fabrics or polymers,metal wires, and metal solids. Typical metals used for radiopacityinclude tantalum, platinum, gold, and the like.

The hemostatic packing device 10 is packaged in a sealed, sterilebarrier package and is sterilized using standard techniques such assteam, cobalt radiation, ethylene oxide, electron beam and the like.

Referring to FIG. 1B, the hemostatic packing device 10 is shown from theside. The substrate 12, the fluid impermeable surface 14, and theadhesive layer 16 are clearly visible in this view.

FIG. 1C illustrates one embodiment of the hemostatic packing device 10that is folded with the fluid impermeable surface 14 facing outward inpreparation for use.

FIG. 1D illustrates another embodiment of the hemostatic packing device10 that is rolled with the fluid impermeable surface 14 facing outwardin preparation for use.

FIG. 2 illustrates another embodiment of the haemostatic packing device10 where the substrate 12 and the impermeable outer surface 14 arefabricated from the same material. In this embodiment, the hemostaticpacking device 10 is fabricated from closed-cell foam. The foam materialallows for a resilient, deformable substrate while maintaining the outersurface 14 that is impermeable to fluid penetration since it is a closedcell structure.

FIG. 3 illustrates the hemostatic packing device 10 where the upper sideof the fluid impermeable surface 14 comprises indentations 18, that maybe in the form of dimpling or waffling of varying depth that are usefulto hold, or carry, and, subsequently deliver thrombogenic,pharmaceutical or antibacterial agents. The indentations 18 are formedusing molds wherein the outer surface 14 of the closed-cell substrate 12is formed against the mold. In another embodiment, the indents 18 areformed by impressing the fluid impermeable outer sheet with a mold orother forming device. In yet another embodiment, the outer surface 14comprises projections, or villi, that serve to trap and carry thepharmaceutical, antibacterial or thrombogenic agents. The projections orindents may be macroscopic or microscopic.

FIG. 4 illustrates another embodiment of the haemostatic packing device10 wherein the substrate 12 forms a polygonal solid. The polygonalsolids include shapes such as brick or rectangular solid, waffle,pyramid, sheet, and oval. The polygonal solids also include extrudedshapes such as cylinders, or extended lengths of cross-sections such asrectangular, oval, circular, trapezoidal, triangular, etc. The lengthsof these devices range from 5 mm to 1000 mm. The width dimensions ofthese devices range from 1 mm to 200 mm. At least part of the outersurface 14 of the hemostatic packing device 10 comprises a fluidimpermeable barrier. This fluid impermeable barrier 14 may be smooth,indented, or covered by villi, or projections. The substrate 12 isfabricated from materials that allow for deformation in the dry or wetstate. These materials include cotton batting, polymeric foams ofvarying densities, sand, polymer beads, oils including silicone oils,water, and the like.

Referring to FIGS. 1A, 1B, 1C, 1D, 2, 3, and 4, the hemostatic packingdevice 10, in another embodiment, comprises a fluid impermeable layer 14that is fabricated from resorbable materials. The substrate 12 may beremoved and the impermeable layer 14 left behind to complete healing.The resorbable layer 14 is fabricated from resorbable materials such aspolyglycolic acid (PGA), polylactic acid (PLA) and the like. The fluidimpermeable layer 14 has a complex surface that comprises indentationsor villi 18.

FIG. 5 illustrates yet another embodiment of the hemostatic packingdevice 10 wherein the device may have fluid reversibly or irreversiblyintroduced to provide for size adjustment. The outer surface 14 of saiddevice 10 comprises an access port 22 for introduction of materials tofill the substrate 12. In this embodiment, the substrate 12 is a fluidimpermeable membrane that is filled with material to achieve the desiredvolume. The substrate 12 membrane is fabricated either from elasticmaterials such as silastic or polyurethane, or it is an inelastic bagwith folds that allow for size increase. The outer surface of thesubstrate 12 preferably is not adhered in all places to the outersurface 14 of said device 10 and optionally a lubricating layer 24 isplaced between the two structures. The outer surface 14 of said device10 is fabricated from either elastic materials such as polyurethane orsilicone rubber, or it is an inelastic material such as polyethyleneterephthalate, polyimide, polypropylene or polyethylene or a copolymerincluding one of these materials. The outer surface 14 of the hemostaticpacking device 10 may be smooth, indented or include villi. The villi orindents may be macroscopic and have size ranges from 0.1 mm to 10 mm.The villi or indents may also be microscopic and difficult to see withthe unaided eye. Such sizes are less than 0.1 mm.

Referring to FIG. 5, in another embodiment, the hemostatic packingdevice 10 comprises a hydrogel material that is placed into a wound andexpands upon absorption of fluids from the patient to compress thewound. In this embodiment, the substrate 12 is fabricated fromhydrophilic hydrogels such as those described by Park et al. and areincorporated herein by reference. Hydrogels are made from materials suchas, but not limited to, carboxymethyl cellulose, cross-linked sodiumstarch glycolate, and cross-linked polyvinylpyrrolidone and the like.The substrate 12 can also be fabricated from a water-absorbable spongethat expands once it becomes wet. The water-absorbable sponge may befabricated from materials such as, but not limited to polyvinyl alcohol,polymethyl cellulose, and the like. In this embodiment, the fluidimpermeable outer surface 14 comprises an opening to allow for fluidpenetration into the substrate 12 to allow the expansion to occur. Thisopening may be the nipple 22 and the fluid to expand the hydrogel orsponge may be injected through the nipple 22. Alternatively, in the caseof the hydrogel, the substrate 12 and the surface 14 may be of the samehydrogel material. Hydrogels generally absorb water but do not adhere tobiological surfaces. The hemostatic packing device 10 fabricated fromhydrogel would be small enough in its dry state to be introduced throughan optional laparoscopic access port and expand due to water absorptiononce placed within the body.

FIG. 6 illustrates the hemostatic packing device 10 being introducedinto a wound 42 in a liver 40 through a laparoscopic instrument 30. Thelaparoscopic instrument 30 is an axially elongate hollow device thatprovides porthole access to the internal organs of a patient.

FIG. 7 illustrates the hemostatic packing device 10 comprising anadhesive strip 28 on one side. The adhesive strip 28 is used to permitattachment of the hemostatic packing device 10 to other similar devicesso as to create an impermeable syncytium or impermeable contiguous mass.The adhesive strip may also comprise an optional peel away cover thatprotects the adhesive strip 28 prior to use.

The peel away cover is fabricated, preferably, from the same materialsuse to fabricate the fluid impermeable outer surface 14 of thehemostatic packing device 10. The adhesive strip is optionallyfabricated from materials such as Velcro® or even self-adhesivematerials such as Coban™, marketed by 3M™. Velcro® is a trademark ofDupont™ and is a hook and loop fastener that is well known in the art.

FIG. 8 illustrates another embodiment of the hemostatic packing device10 further comprising a fluid impermeable drape 32 affixed to thepacking device 10. The fluid impermeable drape 32 is, preferably adheredto the hemostatic packing device 10. The drape 32 comprises an adhesivelayer 36 and a backing layer 38. The backing 38 is, preferably,fabricated from non-elastomeric materials such as, but not limited to,polyethylene, polypropylene, and the like. It is preferable that thedrape 32 does not stretch once applied. The adhesive layer 36 is on thesame side of the drape 32 to which the hemostatic packing device 10 isaffixed. The hemostatic packing device 10 further optionally comprises aseries of straps 34 to assist with fixation of the device to thepatient. The straps 34 are fastened with standard buckles, Velcro or thelike. This embodiment of the device 10 is useful for treatment of woundsto the periphery and especially those wounds that involve vascularinjury. Such periphery includes the thigh, knee, lower leg, arm,shoulder, and forearm.

FIG. 9A illustrates the wound 42 to the liver 40. The liver 40represents an exemplary case of parenchymal tissue that is friable andbecomes severely damaged during an abdominal injury.

FIG. 9B illustrates the wound 42 to the liver 40 being treated byapplication of intra-parenchymal packing using one or more hemostaticpacking devices 10. In this embodiment, two hemostatic packing devices10 are used to provide hemostasis for the wound 42. The hemostaticpacking devices 10 are applied manually via open surgery, in this case.

FIG. 10A illustrates a wound 44 to the periphery and more specifically,the thigh 46. The wound 44 has caused femoral artery 48 to becometransected.

FIG. 10B illustrates the wound 44 to the thigh 46 being treated byapplication of the impermeable hemostatic packing device 10 with anadhesive impermeable drape 32 and straps 34.

In yet another embodiment, a wound closure device is fabricated from amaterial that has skin and wound contact surfaces that are impermeableto water, blood and tissue penetration. Preferably, these wound closuredevices are fabricated from sheets of materials such as, but not limitedto, polyurethane, polypropylene, polyethylene, silicone elastomer, andthe like. The skin contact surface is a biocompatible adhesive and isfurther impregnated with anti-microbial agents such as, but not limitedto, iodine, betadine and the like. The bandage, peripheral hemostasiswrap (PHW), or wound closure device is large enough to completelysurround the wound and seal in the wound so that blood cannot escape.The bandage, optionally, has additional straps that fully surround thebody or appendage and seal with Velcro, buckles, clamps or the like. Thestraps may be fabric or they may be rubberized or coated, fluidimpermeable fabric, or they may be sheets of polymer. The bandage orwound closure device seals the wound against the full systolic bloodpressure and, thus tamponade any bleeding that occurs from damagedvessels other than the one repaired with the shunt 10. The bandagecomprises an adhesive region that sticks to the skin, even if the skinis wet or bloody. The bandage, or peripheral hemostasis wrap, isoptionally maintained in place using straps that wrap around the body orappendage and secure the bandage in place with adequate pressure togenerate pressure tamponade of the wound. Adhesive methodologies willsuffice to hold the bandage in place in many cases. However,non-adhesive methodologies such as hook and loop fasteners or buckleswill work in almost all applications. The straps 34, in a preferredembodiment, are fabricated from materials that have longitudinal oraxial stretch. Stretching of the straps 34 in the lateral direction isnot preferable. Flexibility in both the lateral and longitudinaldirections is preferable for the straps 34. In a preferred embodiment,the straps 34 with latching devices provide the only form of attachmentof the wound closure device to the patient. The straps 34, in oneembodiment, are wrapped one or more times over the liquid impermeableregion of the bandage to provide for extra tightness and control ofpressure. The straps 34 are configured to exert sufficient force on thefluid impermeable bandage to seal the packing device into the wound orany dams or gaskets against the skin in order to prevent or minimizeblood loss from the wound. The straps 34 are further configured todistribute pressure on the body so that a tourniquet effect does notoccur and so that blood flow is not impeded in any area except the wounditself. The straps 34 distribute pressure by maintaining a widefootprint and not kinking so as to form a small width high-tension area,which could be a problem. For short-term applications, the need fortissue impermeability is less important than the need for liquid (e.g.blood and water) impermeability. A scrim, not shown, is also useful toback up the fluid impermeable region 32 and prevent stretching ordistortion of the fluid impermeable drape or region 32. Further, thestraps 34 may be fabricated as a rigid or semi-rigid shell or cuirass toprevent a tourniquet effect from occurring on the limb being treated. Atourniquet effect is that result when a tight band or cord is wrappedaround a limb, thus preventing or restricting arterial blood flow,venous return blood flow, or both.

The preferred wound closure is a large piece of Ioban, a trademark andproduct of 3M Corporation, the non-adhesive side of which is adhered toa piece of woven gauze or mesh to provide adequate structure to the weakmembrane of the Ioban. The Ioban has adhesive and anti-microbialproperties preferred for this application. A strap extending fromopposing ends of the bandage and terminated with Velcro or 3M Coban,which is self-adherent, assists in maintaining pressure against thewound and proving full tamponade of the hemorrhage. In yet a furtherembodiment, the central part of the skin contact region comprises amalleable or conformable pad, preferably adhered to the wound closuredevice, which helps to exert hemostatic force on the wound. Theconformable pad evenly distributes the forces throughout the wound sothat no areas receive either too high a pressure, or too low a pressure,such as would permit further bleeding. The conformable central pad maybe a block of foam covered by the aforementioned impermeable layer, orit may be an impermeable membrane, preferably elastomeric, filled withliquid such as saline or even a particulate material such as, but notlimited to, sand, flour, sugar, silicone oil, or the like. In apreferred embodiment, the material used to form the fluid-tight membraneis liquid impermeable but gas permeable. Materials suitable for suchpermeability requirements include expanded polytetrafluoroethylene(ePTFE) and the like.

FIG. 11 illustrates another embodiment of the present invention. Thehemostatic packing device 10 is in the form of a wound dressing, PHS, orbandage 50. The wound dressing, PHW, or bandage 50 further comprises anoptional gauze or absorbent region 52. The gauze or absorbent region 52may have material bulked up or rolled up to aid in the application ofpressure to cause pressure tamponade of the wound or perforation to thebody. The gauze or absorbent region 52 may alternatively be a fluidpouch, which may be inflated or deflated to apply the required pressuretamponade to the wound area. The gauze or absorbent region 52 is furthercomprised of a peripheral gasket 54 or a plurality of gaskets 54 runningin a honeycomb, rectangular, nested oval, nested rectangle, concentricring, concentric oval, concentric rectangle, or other appropriatepattern throughout and within the gauze or absorbent region 52 of thebandage 50. The gauze or absorbent region 52 preferably furthercomprises a fluid or liquid impermeable barrier that prevents the escapeof blood from the wound area, even under systemic systolic arterialpressure. The gasket 54 is sealed to the fluid or liquid impermeablebarrier to prevent the escape of blood out the side of the bandage atpressures up to that of systemic systolic arterial pressure.

The gasket 54 aids in hemodynamic control and is made out of fluidimpermeable, elastomeric or compliant materials, such as, but notlimited to, silicone, C-flex, hydrogels, silicone oil-filled membrane,polyurethane closed-cell foam, and the like. The typical width of thegasket 54 material will be ⅛ to ¼ inch. However, it should not belimited to these dimensions, as there may be wounds that require greaterhemodynamic stabilization using the here claimed damming concept ortechnique. The gasket 54 is wide enough to distribute pressure over theskin area so as not to cause petcheciae, bruising or tissue damage butenough pressure to seal against systemic arterial pressure, typically100 to 300 mm Hg. The absence of petcheciae is preferable but is notessential for performance of the gasket 54. The gasket 54 should pressinto the skin hard enough to form a complete liquid-impermeable seal.Bruising of the skin is generally considered to be an acceptablealternative to bleeding to death. The dam or gasket 54 generally pressesgently into the tissue surrounding the wound to ensure a strongresistance to hemorrhage or leakage of blood beyond the dam. The gasket54 or dam is configured to indent the skin and seal against the skin soas to prevent the loss of blood at systolic systemic blood pressurelevels. The gasket 54 or dam is configured with a skin contact surfacethat has a cross-section that includes, but is not limited to,triangular, rounded, trapezoidal, rectangular, rounded triangular, andthe like. The gasket 54 or dam further is configured without any bumps,defects, or gaps that wound permit liquid loss between the gasket 54 andthe skin when pressed together. The gasket 54 to skin contact and sealis generally improved by the presence of water, blood, or other liquids.In one embodiment, a fluid impermeable region exists in the area insidethe gasket 54.

Affixed or integral to the gauze or absorbent region 52 is a pluralityof optionally fluid impermeable straps 58 that will wrap around theextremity or wound area. The straps 58 may contain an adhesive layer 36or may be of material suitable for stretch wrapping, or they preferablycomprise mechanical fasteners. Optionally, the straps 58 may comprise anadhesive layer 36 and a backing layer 38. The backing 38 is, preferably,fabricated from non-elastomeric materials such as, but not limited to,polyethylene, polypropylene, Tyvek, polytetrafluoroethylene, polyester,and the like. Another option for the straps 58 could be self-adhesivestraps 58 made from materials such as, but not limited to, thosemanufactured by 3M, Inc., under the trade name of Coban. This materialwould be suitable and desirable for use as the straps 58 due to itschemical composition and inherent antiseptic properties. In addition,the wrapping material may also have buckles or hook and loop fastenerssuch as Velcro 62 or another means of securing or attaching the bandagein place on the patient. Self-adhesive materials such as, but notlimited to, those manufactured by 3M, Inc., under the trade name ofCoban are suitable for use as the binding system for the straps 58. Thestraps 58 may also be fluid impermeable and optionally possess at leastsome degree of elastomeric properties, so as to aid in the woundcontainment. The bandage or wound dressing 50 also has a free end orside 60. Ideally, the wound dressing or bandage 50 would be packagedwith a protective, removable layer over the gauze or absorbent region 52and quite possibly over the entire surface applied to the patient.

The straps 58, in a preferred embodiment, comprise elements, which areelastomeric in the longitudinal direction. The elastomeric members inthe straps 58 make it easier to apply the bandage and facilitatewrapping the straps 58 tightly enough that the bandage is able to sealagainst systemic arterial pressure. It is preferable to size the straps58 to permit the straps to be wrapped around the limb or body part aplurality of times so as to hold the liquid impermeable region and anydams or gaskets tightly over the wound. The straps 58, in oneembodiment, are non-elastomeric or have non-stretching elements affixedthereto in a region encompassing at least the fluid impermeable region.The non-elastomeric or non-stretchable region is generallynon-deformable except in flexion. The straps 58 are sized to fit thebody part being treated. The width of the straps 58 ranges from ½ inchor less to over 36 inches. Preferably the width of the straps 58 rangesfrom ½ inch to 12 inches. The length of the strap 58 is sized to allowfor at least one wrap around the body part, and preferably, a pluralityof wraps.

FIG. 12 illustrates another embodiment of the present invention. Thehemostatic packing device 10 is in the form of a wound dressing orbandage 50, as shown in FIG. 11. The wound dressing or bandage 50further comprises a gauze or absorbent region 52. The gauze or absorbentregion 52 is generally a central region in the bandage that covers thewound. This region 52 in another embodiment, may not be absorbent orgauze covered at all, but merely a liquid impermeable central woundcovering region. The gauze or absorbent region 52 is further comprisedof a plurality of dams or gaskets 54 running or weaving in a honeycomb,rectangular, diamond, or other appropriate pattern throughout and withinthe gauze or absorbent region 52 of the bandage 50. The gasket 54 aidsin hemodynamic control and is made out of fluid impermeable materials,such as, but not limited to, silicone, C-flex, hydrogels, siliconeoil-filled membrane, polyurethane closed-cell foam, and the like. Thetypical width of the gasket 54 material will be ⅛ to ¼ inch. However, itshould not be limited to these dimensions, as there may be wounds thatrequire greater hemodynamic stabilization using the here claimed dammingconcept or technique. The gasket 54 is wide enough to distributepressure over the skin area so as not to cause petcheciae, bruising ortissue damage but enough pressure to seal against systemic arterialpressure, typically 100 to 300 mm Hg. The gasket or dam 54, in oneembodiment, does cause bruising or petcheciae of the skin. The presenceof petcheciae, while not optimal, does not detract from the performanceof the gasket 54 and is generally considered to be an acceptablealternative to bleeding to death. The dam or gasket 54 further comprisesa tissue contacting edge that is configured with a rounded, rectangular,triangular, trapezoidal, rounded triangular or other shapedcross-section. The dam or gasket 54 is pressed against the skin withenough force to prevent the escape of blood under systemic arterialpressures, which can range from 80 mm Hg to over 200 mm Hg. The dam orgasket 54 seals to the liquid impermeable covering of the bandage bybeing integrally formed, by adhesives, by overmolding, by heat welding,by ultrasonic welding, or by another process. The dam or gasket 54 doesnot seal to the skin by adhesives. The use of adhesives in the dam orgasket 54 would be of little value since the bandage would be placed ona wound in an acute setting, which is often, wet, bloody, oily, dirty,or all of the above. In such environments, there are very few, if any,adhesives that could hold a seal to the skin and prevent the escape ofblood under systemic arterial pressure.

FIG. 13 illustrates another embodiment of the present invention. Thehemostatic packing device 10 is in the form of a wound dressing orbandage 50, as shown in FIG. 11. The wound dressing or bandage 50further comprises a gauze or absorbent region 52 and a valve 56. Thevalve 56, which resides within the gasket 54, may be used to removefluids or add agents to assist in the coagulation or wound containment.The valve 56 may be, but is not limited to, a duck bill type of valve,stopcock, or the like.

FIG. 14A illustrates a cross-sectional view of another embodiment of twointernal packs 100 and 102 comprising an impermeable outer layer 16 anda soft-conformable filler region 14. The left hand internal pack 100further comprises a female adhesive region 104 further comprising anadhesive material 106 and a plurality of adhesive material gaps 108. Theright hand internal pack 102 further comprises a male adhesive region110 further comprising an adhesive material 112 and a plurality of dams114.

Referring to FIG. 14A, the left hand internal pack 100 and the righthand internal pack 102, in the preferred embodiment each has at leastone male adhesive region 110 and one female adhesive region 104 so thata plurality of packs can be chained together to form a contiguous bloodimpermeable barrier. In the preferred embodiment, the adhesive material106 is the hook style of Velcro fastener while the adhesive material 112is the tufted style of Velcro fastener. Thus when the adhesive regions106 and 112 are brought into contact, they adhere to each other. Theadhesive regions 106 and 112 are reversibly adherent to each other andmay be separated by manual force, if desired. In another embodiment, theadhesive regions 106 and 112 may be fabricated from materials such as,but not limited to, 3M Coban and the like, hydrogel adhesives and thelike, and typical adhesives such as are used in medical bandages. Theadhesive material gaps 108, in the female adhesive region 104 are spacedand designed so that the dams 114 of the male adhesive region impinge onand seal against an impermeable surface of the female adhesive region104. The adhesive material gaps 108 and the dams 114 may be configuredin a straight line or they may be curved into a wavy pattern to improvethe sealing area. Special guide markers either printed on the packs 100and 102 or fabricated as raised or detented surfaces on the packs 100and 102 facilitate alignment of the dams 114 and the adhesive materialgaps 108.

FIG. 14B illustrates a cross-sectional view of the internal packs 100and 102 following joining to form a continuous barrier pack. Referringto FIGS. 14A and 14B, the dams 114 seal against the impermeable surface16 through adhesive material gaps 108. The adhesive regions 106 and 112are firmly in contact and grip each other to hold the two packs 100 and102 together without any area of seepage, leakage, or weeping.

In yet another embodiment of the barrier pack, the mating region betweenthe two packs comprises adhesive regions such as those described forFIG. 14A, except that the barrier dams are replaced with fluidimpermeable flaps that fold in to cover the adhesive regions followingjoining. One flap preferably covers each side of the adhesive region. Ina preferred embodiment, the flaps cover the adhesive regions until theyare needed to join with another barrier pack. At that time, the flap ispulled away, the two packs are joined, and the flap is folded in tocover the adhesive region and form a fluid-tight seal between the twobarrier packs.

Referring to FIG. 1 through FIGS. 14A and 14B, the hemostatic packingdevice 10 is used to treat wounds that are typically caused by trauma.In a typical procedure, the surgeon or medic, using aseptic procedure,accesses the wound either by open surgery or laparoscopic surgery. Thewound is irrigated and cleaned and excess fluids are removed by suctionand blotting with gauze sponges. The surgeon may apply antiseptic agentsor thrombogenic agents to the wound. The surgeon places the hemostaticpacking device 10 into the wound and the device 10 is secured intoplace. Using current damage control procedure, it is preferable tostabilize the patient prior to removing the hemostatic packing device 10and permanently repairing the wound. The hemostatic packing device 10does not stick or heal into the wound and removal is not traumatic tothe patient. The hemostatic packing device further does not introducecontaminants or debris, a problem with prior art, powdered hemostaticagents, which would be difficult to remove to perform definitive repairand which would increase the likelihood and severity of wound infection.Referring to FIG. 13, he hemostatic packing device 10 is also wellsuited for a typical “sucking chest wound” because of its inherentimpermeable properties. The one-way valve 56 permits fluid and air toexit the chest cavity but prohibits reflux of air into the chest cavity,a condition which prevents lung function and which is known aspneumothorax.

FIG. 15 illustrates a preferred embodiment of a wound dressing orbandage 120. The wound dressing or bandage 120 comprises a backbone 122with a central region and two ends, a first fastener 126, a secondfastener 128, a fluid-impermeable barrier 124, a fluid dam 132, a pillowpack 134, and an optional peripheral hemostatic region 130.

Referring to FIG. 15, the wound dressing or bandage 120 is configured towrap around a body part, arm, leg, torso, head, etc. and fasten usingthe first fastener 126 and the second fastener 128. The bandage 120 ispre-packaged in a barrier package that prohibits contamination.Following packaging, the bandage 120 and package are sterilized usingethylene oxide, gamma radiation, E-beam radiation, or the like. In apreferred embodiment, the package comprises an inner and an outer pouchwhich are sealed and which constitute a double-aseptic package. Thefasteners 126 and 128 are of the type including, but not limited to,Velcro, buckles, snaps, jam cleats, buttons, and the like. Fastener 128is, in a preferred embodiment, a loop fastener, while fastener 126 isthe hook fastener. In another embodiment, there are a plurality of loopfasteners 128 or a continuous loop fastener along a large region of thebandage 120. In another embodiment, a plurality of hook fasteners 126are comprised by the bandage 120. In a preferred embodiment, the hookfastener 126 is affixed at one end and on one side of the backbone 122.The fluid impermeable region and gaskets are affixed to the same side ofthe backbone 122 as the hook fasteners 126. The side of the backbone 122opposite that of the hook fasteners 126 comprises loop structures, suchas those found in Velcro loops, covering essentially the entire side,that compatibly lock or reversibly engage with the hook fastener 126.This configuration is preferable because it permits a wide range ofadjustability in locking the bandage in place. Other conceivable lockstructures are appropriate in this application. An optional cinchmechanism to increase mechanical advantage and allow the caregiver toapply the PHS or bandage 120 with increased compression may be added tothe configuration. The backbone 122 is preferably a woven or knittedfabric of material such as, but not limited to cotton, polyester,polypropylene, polyurethane, polyethylene, PTFE, nylon, and the like.The woven backbone is configured to be flexible but have high tensilestrength, while porosity is not an important characteristic. Theimpermeable barrier 124 is preferably applied to the central region ofthe bandage 120 and is created by a separate polymer layer that isadhered or welded to the backbone 122. The backbone 122 may also bedipped, sprayed, or coated with materials such as, but not limited to,polyurethane, C-Flex thermoplastic, silicone elastomer, and the like.Since the dressing is intended for short-term application, gaspermeability is not considered objectionable but it is desirable. Thefluid dam 132 is fabricated from materials including those used tofabricate the fluid impermeable barrier 124. The fluid dam 132 may alsobe fabricated from gel-filled membranes, hydrogels, oil-filledmembranes, and the like. The membrane of the fluid dam 132 ispreferably, inelastic at the pressures used for filling. The fluid dam132 is configured to provide a pressure seal against the body and form acomplete barrier to prevent blood from escaping the wound. In anotherembodiment, the fluid dam 132 is inflatable following or beforeapplication to the patient through a valve such as a stopcock orstandard inflation valve on the exterior surface of the bandage 120.

Further referring to FIG. 15, the pillow pack 134 is adhered to thecentral region of the bandage 120, preferably adhered to the fluidimpermeable region 124. The pillow pack 134, preferably resides withinthe region described by the fluid dam 132. The pillow pack 134 outersurface is preferably smooth and resistant to blood adherence but inanother embodiment, the pillow pack 134 outer surface may be a fabricmesh or other convoluted surface capable of accelerating thrombosis orof carrying thrombogenic materials or antimicrobial agents. Thethrombogenic materials are preferably spreadable gels or liquids.Typical thrombogenic materials include fibrin, substances that removewater from blood and cause coagulation, or other materials derived, forexample from crustaceans, and which exhibit thrombogenic properties whenexposed to blood. The pillow pack 134 is the primary distributor offorce upon the wound to generate pressure tamponade. The pillow pack 134is capable of extruding into a wound and distributing pressure evenly togenerate hemostasis. The pillow pack 134 preferably comprises anelastomeric membrane filled with materials such as, but not limited to,air, water, oil, sand, gel materials, and the like. The pillow pack 134in the embodiment where gas, air or liquid, is used for inflation,comprises an optional valve such as stopcock on the exterior surface ofthe bandage 120. The peripheral hemostasis region 130 preferably resideswithin the fluid dam 132 and accelerates clotting in the region outsidethe wound area but within the environs of the bandage 120. In apreferred embodiment, the peripheral hemostasis region 130 comprisesmaterials, which are elastomeric thus allowing the pillow pack 134 toapply a predetermined or known amount of force to the wound. Theperipheral hemostasis region 130 is fabricated from materials such as,but not limited to, cotton gauze, polyester knits and the like.

FIG. 16 illustrates another embodiment of a wound dressing or bandage120. The wound dressing or bandage 120 comprises a backbone 122 with acentral region and two ends, a first fastener 126, a second fastener128, a fluid-impermeable barrier 124, an outer fluid dam 132, an innerfluid dam 152, an optional pillow pack 134 (not shown), an optionalperipheral hemostatic region 130, an optional adhesive region 170, and aplurality of lateral stiffeners 150.

Referring to FIG. 16, the backbone 122 provides the structure to whichother components are affixed. The fluid impermeable barrier 124 ispermanently affixed near the central portion of the backbone 122 and issized to completely cover a wound. The fluid impermeable barrier 124 isaffixed to the backbone 122 with adhesives, heat welding, mechanicalinterlocks, or the like. The lateral stiffeners 150 are affixed to thebackbone and prevent lateral collapse or wrinkling of the backbone. Thelateral stiffeners 150 possess column strength and they are flexible.The lateral stiffeners 150 may optionally be elastomeric or stretchbeyond their unstressed configuration but they cannot be substantiallycompressed below their unstressed configuration. The lateral stiffeners150 may be discrete elements, like sail battens, or they may be a sheetof material integral to or attached to the backbone 122. The backbonematerial 122 is preferably permeable to gas or even liquids, however thecentral fluid impermeable barrier 124 is not permeable to liquids suchas blood, water, oil, or the like. In one embodiment, the backbonematerial 122, in the region of the fluid impermeable barrier 124 ispreferably, not elastomeric in either the longitudinal or the lateraldirection.

The inner dam 152 and the outer dam 132 are permanently affixed to thebackbone 122 so that only fluid impermeable barrier exists on theinterior of the outer dam 132. The multiplicity of dams 132 and 152allows greater flexibility in sizing the bandage because only one of thedams needs to provide the seal against systemic arterial pressure. Theexact number of dams 132 and 152 is undetermined and could range fromone to 50 or more. Practically, the number of dams will be in the rangeof 1 to 10, and preferably number two to three. The dams 132 and 152form a concentric or nested pattern of rings that may be ovals, squares,circles, or the like. The dams 132 and 152 have a skin contact surfacethat is even and smooth with no distortion, gaps, dimples, or roughness.The dams 132 and 152 have structure to resist gross distortion butelastomeric enough to cushion the skin when pressed thereon. In anotherembodiment, an asymmetrical tightening mechanism is provided whichallows for relative tightening of one side of the PHS or bandage 120relative to the other. The asymmetrical tightening mechanism isadvantageous, when placing the bandage 120 on a tapered body member suchas a forearm or thigh, to obtain even pressure distribution on the dams132 or 152 or both. The asymmetrical tightening mechanism can also beuseful to cinch the bandage so that observed hemorrhage from beyond thedams 132 and 152 are substantially eliminated. The dams 132 and 152 canrange in height from 0.020 inches to 0.5 inches, and preferably rangebetween 0.08 and 0.250 inches in height. The width of the dams 132 and152 can range between 0.020 and 0.5 inches with a preferred width of0.08 to 0.250 inches.

The optional adhesive region 170 is affixed to the same side of the PHSor bandage 120, as is the dam 132. The adhesive region 170 is locatedadjacent to but outside the dam 132. The adhesive region 170 ispreferably affixed to the PHS or bandage 170 at or near an end. Theadhesive region 170 serves to allow for initial placement andstabilization of one end of the bandage 120 against the patient's bodyso that the PHS or bandage 120 can be wrapped with one hand. Theadhesive region 170 also allows for generation of correct tension whenwrapping the bandage 120 around the body part or limb. In a preferredembodiment, the outer dam 132 is affixed to the backbone 122 relativelycloser to the end of the bandage 120 where the adhesive region 170 islocated than to the other end of the bandage 120. Thus, in thispreferred embodiment, the dams 132 and 152 are located closer to one endof the bandage 120 than to the other end. The adhesive region 170 ispreferably fabricated from adhesives that work in a wet or bloodyenvironment. Such adhesives, while not extremely strong, offersufficient adherence to stabilize the bandage for initial wrapping.Hydrophilic hydrogels and other materials known in the art comprisematerials suitable for fabrication of a wet-adhesive region. Thefastener 128 in a preferred embodiment is the loop of a hook and loopfastener while the fastener 126 is the hook of the hook and loopfastener. In another embodiment, the adhesive region 170 is replaced oraugmented by an elastomeric ring or wrap (not shown) through which thelimb is placed. The ring or wrap is affixed to the backbone 122 at thesame end of the bandage 120 as the adhesive region 170 and temporarilysecures the bandage 120 to the limb until the backbone 122 can bewrapped securely around the limb or body part.

The hemostatic region or zone 130 between the two dams 132 and 152 canbe filled with a biological adhesive prior to adhering the bandage 120to the patient, or the biological adhesive can be applied, in advance,to the hemostatic region 130. The hemostatic region 130 can be coatedwith thrombogenic agent or biological adhesive. Biological adhesives caninclude those fabricated using polyethylene glycol (PEG), 2-arm, 4-arm,or a combination thereof. The biological adhesive can also compriseproteins, or other materials, to interact with the PEG. Suitableproteins can include albumin, either from human, animal, recombinant,etc, or the like. Other materials can include poly (2-hydroxyethylmethacrylate) polyHEMA, or the like. The biological adhesives orthrombogenic substances can be applied to the region 130 between thedams 132 and 152 but should not be applied interior to the inner dam 152since clotting or adhesive characteristics within the inner dam 152,within the region of the wound, would cause the wound to reopen uponbandage removal, or damage the wound so that a trauma surgeon or mediccould have trouble repairing the wound once the patient reached medicalattention. The adhesive material can be coated onto the inner dam 152,the outer dam 132, or both, such that the adhesive material assists withthe seal between the dams 132 and 152, and the skin surrounding thewound. Suitable biological adhesives can be found in U.S. Pat. Nos.6,458,147, 6,371,975, and 6,899,889, the entirety of which are herebyincorporated herein by reference. In another embodiment, the biologicaladhesive, both PEG and albumin or other protein can be applied to thehemostatic region 130 in their dry state or can be applied wet and thendried after application. In their dry state, these materials exhibit noadhesive properties. However, in the presence of water, these materialscan be strongly adhesive to skin or other tissues. The biologicaladhesives or thrombogenic materials, in their dry state, can sustain along shelf life if packaged within a fluid-impermeable package such as afoil package or fluid impermeable polymer. The hemostatic regions 130 orthe dams 152, 132 can be coated with or comprise deformable, gap fillingmaterials, such as, but not limited to, gels, or weak elastomers, fluidfilled bags, or the like, with or without adhesive surfaces, the gapfilling materials being configured to maintain the seal between the dams132, 152 and the skin or the hemostatic region 130 and the skin.

FIG. 17A illustrates a wound 160 covered by a hemostatic bandage 120 orPHS further comprising a liquid impermeable region 124, a strap 166, anda dam 132. The wound is surrounded by a layer of skin 162 with a dimpledregion 164. The strap 166 is of sufficient tightness to hold the dam 132against and pressing into the skin 162 to form a dimple 164 and abarrier against pressurized blood. Blood cannot escape the environs ofthe PHS or bandage 120. The strap 166 is configured with elastomericelements in the longitudinal direction to facilitate generation andcontrol of sufficient tensile forces to cause hemostasis. Theelastomeric elements are fabricated from material such as, but notlimited to polyurethane, Lycra, silicone elastomer, thermoplasticelastomer, and the like. The fabric of the strap 166 may be porous ormay be rubberized or sealed against fluid escape. Elastomeric propertiescan also be achieved by fabric forming processes such as, but notlimited to, weaving, knitting, crocheting, and the like. In anotherembodiment, mechanical elements are provided to tighten the bandagestraps 166 in a controlled fashion. The mechanical tightening elementsinclude winches, pulleys, turnbuckles, levers, inflatable elements suchas bladders, and the like. A plurality of such tightening elements, inone embodiment, are distributed so as to permit selective or controlledtightening of one or both edges of the straps 166. The dam 132 has askin 162 contact surface that is rounded so as to be minimally traumaticcausing temporary dimpling 164.

FIG. 17B illustrates a wound 160 surrounded by a layer of skin 162,covered by a hemostatic bandage 120 further comprising a liquidimpermeable region 124, a strap 166, a dam 132, and a fluid port andvalve 168. The fluid port and valve 168 are affixed to the fluidimpermeable region 124 and permit liquids or gasses to be injected orremoved from the space between the liquid impermeable region 124, thedam 132, the wound 160 and the skin 162. Injection of liquids such assaline or water or even gasses may be advantageous in causingdistributed pressure within the wound 160 to cause hemostasis againstrestricted or unrestricted systemic arterial pressure. Such fluidinjected into the wound region under the liquid impermeable region 124is preferably pressurized to a level exceeding systemic systolicarterial pressure, typically in the range of 100 mm Hg to 250 mm Hg,depending on the level of hypertension of the individual. The dam 132has a skin contact surface that is triangular in cross section with aslight rounding to minimize trauma to the skin 162. The dimple 164 isformed in the skin by the pressure applied to the dam 132. The liquidimpermeable region 124 is held against the skin 162 by the strap orstraps 166 and fastened with fasteners that work in a wet, contaminatedenvironment.

FIG. 18 illustrates yet another embodiment of the bandage 120 wherein itis held against the skin surrounding a wound by a vacuum. In thisembodiment, the bandage 120 comprises a liquid impermeable region 124,an inner dam 152, an outer dam 132, a vacuum port 180, a vacuum valve182, a vacuum manifold 184, a scrim 186, and an optional strap 166. Thefluid port 180 and valve 182 are used to facilitate pulling a vacuumunder the liquid impermeable region 124 of the bandage 120 to hold thebandage 120 in place. A pump to continuously draw a vacuum is preferableto a pump that is deactivated after the vacuum is created, because ofleakage of the vacuum at the seals could occur, resulting in hemorrhagefrom the wound 160, unless the vacuum loss is corrected. The scrim 186is affixed to the liquid impermeable region 124 so as to permit flexionbut not stretch of the liquid impermeable region 124. The scrim 186 mayfurther be extended to provide additional reduction in stretchcharacteristics of the strap 166, which is generally elastic in nature.

In an embodiment, the vacuum is created between an inner dam 152 andouter dam 132 so that the wound 160 is not subjected to the vacuum, butrather the surrounding skin 162. In this embodiment, the outer dam 132may surround a region 4 inches by 4 inches, for example. The inner dam152 may surround a region 3 inches by 3 inches for example. At 2.5 psi,the inner dam 152 and liquid impermeable region 124 are pushed away fromthe skin by a force of 2.5 psi times 9 square inches or 22.5 pounds. Afull or partial vacuum drawn in the space between the inner dam 152 andouter dam 132 will be forced inward at between 14.7 psi and somethingless, such as 10 psi. The area of the region between the two dams 132and 152 is approximately 16 square inches minus 9 square inches or 7square inches. Assuming a loss of 2 square inches to dam or gasketmaterial, the space between the inner and outer dam is approximately 5square inches. With the 10 psi of a partial vacuum exerted on thisspace, the bandage 120 is held against the skin by a force of 50 pounds,twice the force of that exerted by the blood on the center of thebandage 120, thus, even an imperfect bandage 120 or vacuum will firmlyhold to the skin 162 and provide hemostasis. The area of the regioncovering the wound 160 is sized, relative to the area of the regionbetween the inner and outer dams so that the vacuum force alwaysovercomes the blood pressure force and keeps the bandage 120 against theskin 162. The inner dam 132 can be sized to encase a wound ofpractically any size from 0.25 inches in length to a full limbamputation, which may be 10 or more inches in diameter. The regioninterior to the inner dam 132 can be pressurized to assist withhemostasis control even though a vacuum is being drawn to keep thebandage 120 in place, as long as the net pressure force does not exceedthe net vacuum hold-down force.

The port 180 communicating between the space between the inner dam 152and outer dam 132 through the fluid impermeable region 124 or membraneconnecting the dams to a region outside the bandage 120 is connected toa vacuum generation device such as a bulb with one or more one-wayvalves, or another type of vacuum pump. The vacuum port 180 furthercomprises a vacuum valve 182, which prevents disabling of the vacuum butmay be opened to relieve the vacuum when desired. The strap 166 isoptional in this embodiment but can assist in positioning the bandage120 and keeping a good seal with the skin 162 while the vacuum is beinggenerated. The vacuum therefore generates all or some of the forceholding the bandage 120 to the skin 162. The bandage 120 furtherpreferably comprises a delivery channel for the vacuum or vacuummanifold 184, which is optional, so that the region between the two dams132 and 152 does not collapse and prevent full distribution of thevacuum. The vacuum port 180 is in fluid communication with the innerlumen of the vacuum manifold 184, if the vacuum manifold 184 is used.The vacuum manifold 184 is a structure, such as a perforated tube thatis operably connected to the vacuum port 180 and will not collapse underapplication of the vacuum and will allow the vacuum to be exerted evenlyaround the region between the two dams 132 and 152. In the embodimentwhere the vacuum manifold 184 is not used, the vacuum port 180 is indirect fluid communication with the region between the two dams 132 and152.

FIG. 19 illustrates a cross-sectional view of a limb or appendage 200with a bandage 202 affixed thereto. The bandage 202 comprises a fluidimpermeable region 204, a dam 206, a strap 208, a fastener 210, a scrim212, and a standoff 214. The body appendage 200 further comprises awound 216, a severed blood vessel 218, and skin 220. A space 222 existsbetween the strap 208 and the appendage 200.

Referring to FIG. 19, the standoff 214 prevents the strap 208 fromtightly encircling the limb or body appendage 200 in such a way that atourniquet effect is created, thus preventing the flow of blood totissues distal to the bandage 202 or the return of venous blood from theregion anatomically distal to the bandage 202. The strap 208 is pulledtightly enough that the component of the force exerted by the strap 206on the dam 206 that forces the strap 206 into the skin 220 is sufficientto overcome systemic arterial pressure. Generally one or two straps 206are required. By creating spaces or gaps 222 along the side of the limb200 between the limb 200 and the strap 206, pressure forces created bythe strap 206 do not prevent the flow of blood through vasculaturewithin the limb 200. The fastener 210 is a buckle or hook-and-loopmaterial such as Velcro and may further comprise a lever to create amechanical advantage to increase tightness of the strap 206 around thelimb 200. The strap 206 is fabricated from woven or knitted materialsincluding but not limited to polyester, nylon, cotton, polyurethane,combinations of the aforementioned, or the like. The strap 206 mayfurther be a bolt or rigid member fabricated from polymer or metal withtelescoping or foreshortening and locking apparatus or means. A threadedbolt traversing the standoff 214 and the scrim 212 is tightened by useof a threaded nut exterior to the standoff 214, the scrim 212 or both.The scrim 212 is a stiffening member that is either fully rigid,partially rigid, or flexible so as to bend outside the plane of thescrim 212. The scrim 212, however, is inelastic and will not deformwithin the plane of the scrim 212. The standoff 214 is generally rigidor semi-rigid and preferably comprises padding on the surface that comesinto contact with the limb 200. The fluid impermeable region 204 and thedam 206 are generally fabricated from soft, elastomeric materials suchas but not limited to, C-Flex, polyurethane, silicone elastomer,hydrogel, or the like. In this embodiment, the force holding the bandage202 against the skin is substantially non-radially distributed, but is,instead, along only one axis.

FIG. 20 illustrates another embodiment of the peripheral hemostasissystem 320 further comprising an upper shell member 314, a lower shellmember 312, a hinge 306, a separation line 308, a latch 300 furthercomprising a tab 302 and a catch 304, a dam 206, an optional pad 310,and a fluid impermeable barrier 204. The peripheral hemostasis system320 is wrapped around a limb 200 further comprising a bone 316, a bloodvessel 218, a wound 216, and a skin layer 220. A gap 222 exists in atleast one circumferential region between the limb 200 and the shellhalves 312 and 314.

Referring to FIG. 20, the upper shell member 314 and the lower shellmember 312 are rigid or semi-rigid structures that are rotatably affixedto each other by the hinge 306. The upper shell member 314 abuts thelower shell member 312 at the separation line 308, which exists on thehinge 306 side and the latch 300 side, when the shell 320 is closedaround limb 200. This type of device 320 is also known as a cuirass. Thefluid impermeable barrier 204 and the dams 206 surrounding the barrier204 are affixed to the inner aspect of the upper shell member 314. Thepad 310 is affixed to the interior aspect of the lower shell member 312.The latch 300 is preferably formed integrally to the upper shell member314 and the lower shell member 312 and is a simple snap latch. Otherlatches 300 include, but are not limited to, snaps, buckles, zippers,buttons, Velcro, pushbutton latches, slide latches, bayonet catches,screw fixation, and the like.

The upper shell member 314 and the lower shell member 312 are fabricatedby injection molding, metal forming, die stamping, blow molding,laminating, or the like, using materials including, but not limited to,thermoplastics, steel, aluminum, polysulfone, polystyrene, polyethylene,polyester, polycarbonate, polyvinyl chloride, and the like. The latch300 components 302 and 304 are similarly fabricated and are eitherintegral to the upper and lower shell members 314 and 312 or they areseparately fabricated and affixed using adhesives, screws, rivets, orthe like. Provision for size adjustability can be made with theperipheral hemostasis system 320 using, for example, internal cinchesand straps, different thickness padding 310, variable catch locations onthe latch 300, a multi position hinge 306, and the like. The peripheralhemostasis system 320 creates a closure and sealing force directedsubstantially along only one axis. The peripheral hemostasis system 320does not, in this embodiment, create uniform radially inwardly directedforces that completely circumnavigate the appendage, a situation thatcould reduce venous return blood flow and cause a tourniquet effect.

The peripheral hemostasis system 320 is provided opened and in acontainer which is sealed from contamination. The peripheral hemostasissystem 320 is preferably sterilized using ethylene oxide, gammaradiation, electron beam irradiation, or the like prior to use. A singleor double aseptic pouch, such as one fabricated from Tyvek, is apreferred container for the peripheral hemostasis system 320. Theperipheral hemostasis system 320 is removed from its aseptic containerand placed around the limb 200 so that the dams 206 impinge on the skin220 surrounding the wound 216. The upper shell member 314 is broughtinto apposition with the lower shell member 312 and the latch 300 isengaged making sure a tight seal occurs between the dam 206 and the skin220. Thus, blood escaping from the blood vessel 218 cannot escape theenvirons of the wound 218 and the patient cannot bleed to death. At theminimum, blood loss is greatly slowed minimizing the chance of bleedingto death during transport to a medical facility. The space 222 betweenthe shell parts 314 and 312 and the limb 200 make sure that force isonly applied in one direction to the limb. Force in the orthogonaldirection is not applied so a complete seal is not created around thelimb 200. Thus, the potential for venous return being compromised isreduced and the tourniquet effect is eliminated or reduced.

FIG. 21A illustrates a side breakaway view of a hemostatic pack 2100comprising a core 2102 of higher spring force material, a surroundinglayer 2104 of softer material, and an outer fluid-impermeable layer2106.

Referring to FIG. 21A, the surrounding layer 2104 can be bonded to thecore 2102 or it can be placed around the core 2102 without bonding,welding or other fastening system. The fluid-impermeable layer 2106 canbe placed around the concentric core 2102 and surround layer 2104 withor without attachment to the surround layer 2104. The fluid-impermeablelayer 2106 can be welded, bonded, heat-sealed, or encased in liquid formand allowed to solidify around the surround layer 2104. The core 2102can be open-cell foam, closed-cell foam, an elastomeric polymer, gel,particulates, or the like. The core 2102 can be fabricated frommaterials such as, but not limited to, polyurethane foam, polycarbonatefoam, thermoplastic elastomer, silicone elastomer, and the like. Thecore 2102 can be foam that is pre-compressed to increase its spring-backforce or effective hardness. The core 2102 can have at least onedimension compressed between 10% and 90%, and preferably 30% to 80%, toachieve the desired amount of hardness or spring rate. In anotherembodiment, the core 2102 can be compressed in more than one dimension,for example diameter and length, or width and height.

The surround 2104 can be fabricated from the same materials as the core2102 or it can be fabricated from gel, liquid, particulates, or othermaterials that can move and re-shape themselves to distribute forces.The surround 2104 can be pre-compressed to achieve a desired degree ofspring-back or resiliency. The surround 2104 can have one or moredimension (e.g. length, diameter, width, etc.) compressed by between 10%and 90% of its unstressed dimension, and preferably between 20% and 70%of said dimension. The fluid impermeable layer 2106 can maintain thecore 2102 and the surround layer 2104 in their pre-compressed states.The fluid-impermeable layer 2106 can further comprise flocking, fibers,dimples, protrusions, outer layers of woven, knitted, or braided fabric,or the like. The fluid impermeable layer 2106 can be fabricated frompolyethylene blends, HDPE, LDPE, polyurethane, silicone elastomer,thermoplastic elastomer, polyester, and the like. The thickness of thefluid impermeable layer 2106 can range from 0.0001 inches to 0.01 inchesand preferably between 0.001 inches and 0.005 inches.

FIG. 21B illustrates a lateral cross-section of the tissue-packingdevice 2100 of FIG. 21A, taken along the section A-A. The tissue-packingdevice 2100 comprises the core 2102, the surround layer 2104, and theouter fluid-impermeable layer 2106. The advantage of this embodiment ofthe packing device 2100 is manufacturability, cost effectiveness, andcontrol over the resiliency of the materials. The device 2100 can befabricated using biocompatible materials, it can be sterilized, it canfurther comprise radiopaque markers embedded therein, and it can beprovided with a variety of outer surfaces to provide the correct amountof tamponade and thrombogenic properties to the tissues within it isbeing placed. The packing device 2100 can be configured for short-term,long-term, or permanent implantation. Embodiments of the packing device2100 are superior to other packing devices of the prior art in that theycan apply pressure, in excess of 70 to 250 mm Hg, sufficient to staunchan arterial bleeding situation whereas the devices of the prior art areinsufficiently resilient to push against tissue and stop the hemorrhageagainst systemic arterial pressure.

The present invention is suitable for wounds to many parts of the body.The external hemostatic pack works on the arms, the legs, the head, afinger, the torso, or various extremities, etc. The present inventionalso describes a fluid or liquid-impermeable band-aid type device withthe further enhancement that a fluid-tight dam is comprised within thedevice to prevent blood loss out the side of the band-aid. The dam, in apreferred embodiment, does not use adhesives to attach or seal to thebody, but rather is attached with mechanical locks and straps sinceadhesives often fail in a wet or contaminated environment. The dam andliquid impermeable wound covering part of the bandage are preferablyconformable to different body curves but still retain the substantialpart of their width and length when applied. The dam and liquidimpermeable region further are configured to prevent or minimizedistortion, wrinkling, kinking, or the like. Such prevention ofdistortion, wrinkling, or kinking is accomplished, in a preferredembodiment by the use of stiffeners laterally disposed across thebandage to prevent lateral compression. These stiffeners allow forflexibility but provide column strength to prevent lateral collapse ofthe bandage. In yet another embodiment, the hemostatic packing device isfilled through a valved port operably connected to the region inside thedam and underneath the liquid impermeable barrier. The hemostaticpacking device can be pressurized with fluids such as air, water,antibiotic material, saline, and the like. Such pressurization to levelsat or above systemic arterial pressure assists in even distribution ofsaid pressure and is capable of further assisting with hemostasis.

The present invention includes apparatus and methods for treatingwounds. The present invention, and the means described herein foraccomplishing said wound treatment, may be embodied in other specificforms without departing from its spirit or essential characteristics.For example, although the preferred embodiment comprises a sterilebandage or packing device in an aseptic transfer package, a non-steriledevice may also be appropriate in certain instances. Further, the strapmeans, used to hold the fluid impermeable barrier and dams against theskin, may be replaced with a rigid or semi-rigid shell, split to form ahinged or connected pair of clamshells which may be opened and thenclosed and locked around an appendage. The shell is, in one embodiment,a pair of “C” shaped members forming a bracelet. The shell could besquare and the blood seal be tightened with a plate and a jackscrew witha handle or knob. This shell, or cuirass, is able to force the fluidimpermeable barrier and dams, pre-mounted to a rigid or semi-rigidbackbone, frame, or scrim, against the patient to force the dams intothe skin without causing the tourniquet effect of a tightly wrappedstrap. Thrombogenic or antimicrobial agents could be applied to anyregion of the peripheral hemostasis system. Adjustment means, such as ajackscrew or a lever and ratchet is used to control the amount of forcewith which the dams are impressed into the skin to cause the fluid-tightseal. The described embodiments are to be considered in all respectsonly as illustrative and not restrictive. The scope of the invention istherefore indicated by the appended claims rather than the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. A system for packing a wound and achieving hemostasis comprising: aplurality of three dimensional packs, each said pack comprising a soft,pliable substrate at least partially covered with a fluid impermeablecovering, wherein the substrate of at least one pack amongst theplurality of packs comprises a bladder and a port for intra-operativelyfilling the bladder with fluid, gel, or particulates; and a releasableattachment adapted for releasably securing each pack to at least oneother pack amongst the plurality of packs.
 2. The system of claim 1wherein the releasable attachment means comprises a hook and loopstructure.
 3. The system of claim 1 wherein the substrate comprisesfoam.
 4. The system of claim 1 wherein at least one pack amongst theplurality of packs further comprises a plurality of indentations on thecovering, said indentations adapted to carry haemostatic or thrombogenicagents.
 5. The system of claim 1 wherein at least one pack amongst theplurality of packs further comprises anti-pathogenic or haemostaticagents disposed on the covering.
 6. The system of claim 1 wherein thesubstrate of at least one pack amongst the plurality of packs comprisesa water swellable hydrogel and a fluid permeable region configured topermit liquids to migrate into the water swellable hydrogel such thatthe water swellable hydrogel swells from a first smaller size to asecond larger size.
 7. A system for packing a wound and achievinghemostasis comprising: a plurality of three dimensional packs, each packcomprising a soft, pliable substrate at least partially covered with afluid impermeable covering; and a releasable attachment adapted forreleasably securing each pack to at least one other pack amongst theplurality of packs; wherein the substrate of least one pack amongst theplurality of packs comprises at least a core layer and a surround layer,the surround layer being a softer material than the core layer.
 8. Amethod of achieving wound hemostasis comprising the steps of: providinga plurality of haemostatic packing devices, each of said devicescomprising a three-dimensional conformable mass with a fluid impermeablecover on at least a part of its exterior surface; packing the wound byplacing a plurality of the haemostatic packing devices into the woundand inflating said devices with fluid, gel, or particulates; andremoving said devices once haemostasis is achieved.
 9. The method ofclaim 8 wherein the placement of said devices is accomplished with anaxially elongate placement device.
 10. The method of claim 8 wherein theconformable mass retains sufficient hardness to exert pressure of atleast systemic arterial pressure against the wound.
 11. The method ofclaim 8 wherein deflation or inflation of said devices is accomplishedthrough an axially elongate hollow introduction device.
 12. The methodof claim 8 further comprising the step of affixing at least one of theplurality of haemostatic packing devices to at least another haemostaticpacking device.
 13. The method of claim 8 further comprising the step ofplacing the haemostatic packing device within the wound with an axiallyelongate placement device, wherein the axially elongate placement deviceremains within the wound along with the haemostatic packing device forat least a portion of the time prior to removal of the haemostaticpacking device.
 14. A method of achieving wound hemostasis comprisingthe steps of: providing a plurality of three-dimensional haemostaticpacking devices, each of said devices comprising a conformable mass witha fluid impermeable cover on at least a part of its exterior surface,further wherein the conformable mass comprises an inner layer that isresilient but relatively hard and an outer layer that is softer, andmore conformable, than the inner layer; packing the wound by placing aplurality of the haemostatic packing devices into the wound such thatthe hemostatic packing devices exert pressure greater than arterialpressure on the tissues in the region of the wound; and removing thehemostatic packing devices from the wound prior to performing definitivewound repair.
 15. The method of claim 14 wherein the cover of thehaemostatic packing devices further comprises anti-microbial orthrombogenic agents.
 16. The method of claim 14 further comprising thestep of affixing at least one of the plurality of haemostatic packingdevices to at least one other of the plurality of haemostatic packingdevices.
 17. The method of claim 14 wherein the plurality of haemostaticpacking devices are packaged within a sterile barrier and sterilizedprior to use.
 18. The system of claim 7 wherein the core layer comprisesa higher spring force than the surround layer.
 19. The system of claim 7wherein the core layer and the surround layer comprise foam.